At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 33 enrolled
Drug / intervention
Emapalumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Two-cohort, Open-label, Single Arm, Multicenter Study to Evaluate Efficacy, Safety and Tolerability, PK and PD, of Emapalumab in Children and Adults With MAS in Still's Disease or With MAS in Systemic Lupus Erythematous
In Brief
A Phase 3 clinical trial evaluating Emapalumab for Macrophage Activation Syndrome and 6 related conditions. Completed, enrolled 33 participants across 44 sites in 13 countries.
Detailed Summary
The purpose of this study is to assess the safety, tolerability and efficacy of emapalumab in children and adults with macrophage activation syndrome (sHLH/MAS) in Still's disease (including systemic juvenile idiopathic arthritis and adult onset Still's disease) or with sHLH/MAS in systemic lupus erythematous, resenting an inadequate response to high dose glucocorticoid treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMacrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis, Still Disease, Systemic Lupus Erythematosus, SJIA, AOSD, MAS
CountriesBelgium, Canada, China, Czechia, France, Germany, Italy, Japan, Netherlands, Poland, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedAug 2021
Enrollment StartDec 2021
Primary CompletionJun 2024
Study CompletionJun 2025
TodayJul 2026
First PostedAug 12, 2021
Enrollment StartDec 15, 2021
Primary CompletionJun 30, 2024
Study CompletionJun 4, 2025
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 4.9 years ago
Interventions
Emapalumabdrug
Emapalumab iv infusion